drugset / Trial / NCT01471379

Milnacipran (Savella) in Irritable Bowel Syndrome (IBS)

NCT01471379

RandomizedParallel-groupDouble-blindTreatment

Summary

Purpose: The investigators are proposing to examine the use of Savella® (Milnacipran) for treating irritable bowel syndrome (IBS) in women. Participants: Eligible participants will meet the Rome III diagnostic criteria for IBS. Procedures: This study will observe patients treated with Savella® as well as patients treated with a placebo (pill with no active drug). The investigators will monitor and compare several patient and symptom related outcomes, as well as evaluate health related quality of life, psychological distress and related psychosocial measures to determine if the addition of Savella® improves clinical pain response as well as secondary outcomes including quality of life.

Timeline

Start
2012-04
Primary completion
2013-02
Completion
2013-02

Drugs

EvaluationDrugModalityDoseRoute
Comparator Milnacipran Other / unclassified 50 mg Oral
Comparator Milnacipran Other / unclassified 100 mg Oral